Postnova Analytics (Germany)

BackgroundAtrial fibrillation (AF) affects 2% to 4.5% of the population. Catheter ablation, a key strategy for paroxysmal AF management, can be achieved through radiofrequency (RFA), cryoablation (CBA), or pulsed field ablation (PFA). While clinical outcomes are well studied, their environmental impact remains underexplored.ObjectivesThis study modeled the environmental impact of CBA and PFA ablation techniques in Europe, aiming to provide evidence to guide sustainable practices in AF treatment.MethodsAn early environmental analysis compared pentaspline PFA (Farapulse system, Boston Scientific) with CBA using a decision-analytic model. The model simulated the patient care pathway from a hospital perspective over a 1-year time horizon, considering index and redo procedures, and complications. The environmental impact, linked to resource use, was measured in kilograms of CO2 equivalents (kg CO2eq), incorporating length of stay, intervention time, anesthetic use, and complications. Probabilistic and scenario analyses, including a comparison with RFA, were performed to assess uncertainty and robustness of the results.ResultsThe environmental analysis showed that PFA resulted in total emissions of 13 899 kg CO2eq, compared with 16 383 kg CO2eq for CBA (−2483 kg CO2eq, −15.2%) per 100 patients. Monte Carlo simulation results confirmed these findings, showing median savings of 2409 kg CO2eq (95% credible interval: 581-4312 kg). Parameters, such as anesthesia time and anesthetic drug use, were key drivers of the results. In the RFA scenario analysis, PFA yielded a saving potential of −4640 kg (−25%). In Germany, for example, with approximately 24 000 CBA procedures annually, PFA adoption was projected to reduce emissions by 509 723 kg CO2eq.DiscussionPFA showed potential for reducing emissions by approximately 25 kg CO2eq per patient compared with CBA, driven by lower resource use. These findings aligned with studies identifying operating rooms and anesthetic drug use as major contributors to hospital emissions. A study limitation was the lack of data on catheter manufacturing and disposal.ConclusionsPFA was expected to reduce emissions compared with CBA in AF patients. Conscious medical device choices can foster more sustainable hospital practices. A full life-cycle analysis of catheters is needed to validate these findings.

Aim The objective of this study was to assess the burden of hospital-acquired venous thromboembolism (VTE) on healthcare systems and patients across ten countries. Methods A multi-methodological approach was taken to estimate the burden of hospital-acquired VTE across five key clinical specialties and ten countries (Australia, Brazil, China, France, Mexico, South Korea, Spain, Taiwan, Thailand, and the United Kingdom). Surveys with healthcare professionals (surgeons, hematologists, and hospital management) were conducted to identify clinical specialties of interest. A systematic literature review and interviews were conducted to identify data for incidences and costs. A health-economic model was developed, using a decision tree and Markov model to estimate 1-year costs. Costs are presented in 2022 USD. Results Orthopedics, oncology, long-term ICU, cardiology, and obstetrics and gynecology were identified as the clinical specialties of interest. The total cost burden of hospital-acquired VTE was estimated to be $41,280 million, which equals $503 per patient at risk. Expressed as a share of 2022 GDP, an average spending per country of 0.05% to 0.18% was observed. The VTE-associated mortality was substantial, accounting for 150,081 deaths in a 74.2 million population, translating into an average mortality rate of 2.02 (0.64–3.05) per 1,000 patients at risk. Limitations There were limited data available concerning VTE incidences in some countries and clinical specialties. Where data were available, there was heterogeneity of incidence definitions across the identified studies. Generalizations, imputations, and the country-agnostic structure of the model might have contributed to biases. Conclusions The burden of hospital-acquired VTE is substantial both from an economic and from a patient perspective in all countries evaluated.

The recent transformation of the energy sector brings new challenges in areas such as supply security, efficiency and reliability. Especially the increase of decentralized power plants leads to a more complex energy system and an increasing complexity. This requires expansion and digitization of the power grid as well as an initiative-taking operation of the grid operator. To investigate such complex systems and its phenomena, modern development methods such as real-time simulation or digital twins (DT) can be used. In this approach a digital replica of the real-world system, a grid section, is developed, which can represent or predict the behavior of the real distribution grid. For this, a model of the real-world system is derived and implemented in a co-simulation environment, in which it receives data via an analyzer or measurement system from the grid model. This paper focuses on the development of the digital twin of a testing grid and a grid analyzer for the measurement. With the digital twin of the testing grid, a first approach is achieved in a real-time capable environment showing the functionalities and interactions of a digital twin. Subsequently the development of the digital twin model is explained, and the results are discussed

PurposeCellulose nanocrystals (CNC) play a promising role in the development of new advanced materials. The growing demand of CNC-containing products in the food industry will lead to an increased human exposure through oral uptake. To date, there is a dearth of studies reporting on the risks which CNC pose to human health following ingestion. In vitro models, which lack physiological accuracy, are often used to justify animal experiments in the field of nanosafety assessment. Nevertheless, ex vivo models of the intestine pose promising alternatives to in vivo experiments.MethodsTwo ex vivo models, a microfluidic chip based on porcine intestinal mucus and the Ussing chamber apparatus with tissue from abattoirs, which aim to complement in vitro models, are characterized by investigating the transport and toxicity of CNC through them in comparison to an in vitro triple co-culture model. Silver nanoparticles were included in this study as well-known and characterized nanomaterials for comparative purposes.ResultsStudy results show that CNC cross the intestinal mucus layer but do not pass the intestinal tissue barrier ex vivo and in vitro; furthermore, no toxic effects were observed under exposure conditions tested.ConclusionThese ex vivo models present complementary methods to the existing standardized in vitro and in silico methods to support data generation under physiologically relevant conditions without the use of animals. This multi-model approach offers an enhanced understanding of the complex interaction between new materials and human tissue and aligns with the flexible approach of IATA (Integrated Approaches to Testing and Assessment) and NAMs (New Approach Methods) for chemical and drug safety assessment.

Abstract We present a generically applicable approach to determine an extensive set of size-dependent critical quality attributes inside nanoparticulate pharmaceutical products. By coupling asymmetrical-flow field-flow fractionation (AF4) measurements directly in-line with solution small angle X-ray scattering (SAXS), vital information such as (i) quantitative, absolute size distribution profiles, (ii) drug loading, (iii) size-dependent internal structures, and (iv) quantitative information on free drug is obtained. Here the validity of the method was demonstrated by characterizing complex mRNA-based lipid nanoparticle products. The approach is particularly applicable to particles in the size range of 100 nm and below, which is highly relevant for pharmaceutical products – both biologics and nanoparticles. The method can be applied as well in other fields, including structural biology and environmental sciences.

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